Deviation Investigator Level 2
Lonza
Summary
The Deviation Investigator II is responsible for leading and executing deviation investigations within a cGMP environment, with a focus on identifying root cause and implementing effective corrective and preventive actions (CAPAs). This role operates with a higher level of independence and plays a key part in mentoring junior investigators and driving investigation quality.
Job description
What you will do
- Independently lead and complete minor deviation investigations
- Support and contribute to major deviation investigations with guidance from team leadership
- Provide direction and mentorship to Level I investigators, helping to elevate team capability and consistency
- Make real-time decisions related to deviation containment and investigative approach
- Utilize a range of root cause analysis (RCA) tools (e.g., 5 Whys, fishbone, cause mapping) to drive thorough investigations
- Manage a moderate workload of concurrent investigations, ensuring timely and high-quality completion
- Drive strong documentation practices with a target of >80% Right First Time (RFT)
- Partner cross-functionally to gather information, resolve issues, and ensure alignment
- Develop and implement effective CAPAs to prevent recurrence
- Maintain compliance with cGMP, GDP, and data integrity standards
- Facilitate meetings, navigate conflict, and communicate effectively with stakeholders
- Perform additional duties as assigned
What we are looking for
- Bachelor's degree in Life Sciences, Engineering, or a related field, with 3-5+ years of experience in a GMP-regulated environment (Quality Assurance or similar function)
- Strong working knowledge of cGMP, Good Documentation Practices (GDP), and data integrity principles
- Proven experience leading deviation investigations and applying root cause analysis tools (e.g., 5 Whys, fishbone, cause mapping) and CAPA development
- Ability to manage multiple priorities, make sound decisions, and deliver on timelines in a fast-paced environment
- Strong technical writing skills and attention to detail, with a focus on compliant, high-quality documentation
- Effective communication and collaboration skills, with the ability to work cross-functionally and mentor junior team members
- Demonstrated problem-solving ability and a proactive, solution-oriented mindset
- Proficiency in Microsoft Office (Excel, Word, PowerPoint); experience with biologics or mammalian processes strongly preferred
Requirements
- Bachelor's degree in Life Sciences, Engineering, or a related field
- 3-5+ years of experience in a GMP-regulated environment (Quality Assurance or similar function)
- Strong working knowledge of cGMP, Good Documentation Practices (GDP), and data integrity principles
- Proven experience leading deviation investigations and applying root cause analysis tools (e.g., 5 Whys, fishbone, cause mapping) and CAPA development
- Ability to manage multiple priorities, make sound decisions, and deliver on timelines in a fast-paced environment
- Strong technical writing skills and attention to detail
- Effective communication and collaboration skills
- Demonstrated problem-solving ability and a proactive, solution-oriented mindset
- Proficiency in Microsoft Office (Excel, Word, PowerPoint)
- Experience with biologics or mammalian processes strongly preferred
Benefits
- Medical, Dental & Vision
- Career Development
- Performance-Based Compensation
- Collaborative Environment
Company overview
Lonza is a pioneering global Contract Development and Manufacturing Organization (CDMO) and a world leader in pharmaceutical manufacturing services. Founded in 1897 in Switzerland, the company has evolved into the first and original CDMO, now operating as one of the largest Western CDMO networks with approximately 19,000 employees across more than 30 sites spanning five continents. Lonza specializes in transforming therapeutic discoveries into life-saving and life-enhancing treatments for patients worldwide. The company's comprehensive services span from early development to drug substance and drug product manufacturing, covering established and emerging technologies including mammalian biologics, small molecules, highly potent APIs, bioconjugates, mRNA, microbial products, and cell and gene therapies. With a focus on cutting-edge science, smart technology, and lean manufacturing, Lonza serves a diverse customer base ranging from emerging biotechs to global pharmaceutical companies, delivering integrated solutions throughout the entire treatment lifecycle.